Mesh Fixation and Closure of Peritoneum Following Laparoscopic Hernia Repair Using N-butyl Cyanoacrylate

Not Applicable

Completed

• Conditions: Hernia, Inguinal

• Registration Number: NCT02457728
• Lead Sponsor: St John of God Hospital, Vienna

Brief Summary

Fixation of mesh and peritoneal closure during TAPP repair using n-butyl cyanoacrylate.

Detailed Description

During transabdominal pre peritoneal (TAPP) hernia repair a mesh should be fixed at four pre-determined points. Number of attempts to fix the mesh with a novel non-penetrating fixation device (LiquiBandFix8) will be recorded. This novel device uses n-butyl cyanoacrylate and a defined amount of glue can be delivered with this 5mm laparoscopic instrument (liquid anchors).

In addition, closure of peritoneum should be accomplished using this device.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-05-17
• Study First Submitted QC: 2015-05-28
• Study First Posted: 2015-05-29
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2015-08-16
• Status Verified: 2015-10
• Results First Submitted QC: 2015-11-08
• Last Update Submitted: 2015-11-08
• Results First Posted: 2015-12-11
• Last Update Posted: 2015-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Inguinal hernia,
• femoral hernia

Exclusion Criteria

• pregnancy,
• not able to understand patient information

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With Safe Fixation of Mesh and Closure of Peritoneum by Clinical Investigation During Hospital Stay and Telephone Interview at Six Weeks Postoperatively.	During hospitalization and 6 weeks after surgery.	Clinical examination during hospital stay to rule out any bowel obstruction due to insufficient closure of peritoneum. Telephone interview at six weeks postoperatively to record any adverse events in the early postoperative period such as recurrent hernia, pain or bowel obstruction.

Trial Locations

Locations (1)

St John of God Hospital; 🇦🇹 Graz, Steiermark, Austria